The Medical Device Single Audit Program (MDSAP) is a certification program endorsed and acceded by health regulators in the United States (FDA), Australia (TGA), Brazil (ANVISA), Canada (HC) and Japan (MHLW). MDSAP audits the medical device manufacturer’s quality management systems by the required standards of the above-mentioned jurisdictions. MDSAP certification requires the safety and quality of the medical devices to exceed the requirements set by the ISO13485 standard. This is done through extensive and meticulous auditing to ensure that the products are designed, produced, installed, and serviced with the highest quality achievable.
In November 2018, WAT Medical received its first the MDSAP certificate issued by BSI, becoming the first medical device manufacturer within the its specialty product industry to obtain the certificate. The company has been adhering to the principle of “quality products and excellent services” for many years, and has obtained the medical device registration certificates within the United States, European Union, Canada, Australia, Israel, and Brazil. The products have been distributed to more than 30 countries around the world. WAT Medical has obtained 65 intellectual property rights and patents worldwide.
In November 2021, WAT Medical passes the annual MDSAP annual audit once again. This is definitive evidence of the company’s outstanding product quality management with its four consecutive years of adherence to the consistent goal to provide excellent products and services. The company will continue to use the knowledge and resources it has gathered to further elevate the standard of quality management for its future products.